EUCTR2013-002770-43-ES进行中（未招募）1 期
Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria. - CUN-OMAL-UCO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult female and male patients (age 14 years or older).
- •- Diagnosis of cholinergic urticaria trough clinical history and positive exercise challenge test.
- •- Non-respondent to supra therapeutic doses of antihistamines (defined as two folds the maximal dose included in the drug labeling)
- •- Written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •- Pruritus related to dermatitis or other skin condition.
- •- Any systemic disease that hampers follow up or interpretation of data.
- •- Omalizumab treatment within the previous 12 months.
- •- Any contraindication included in the drug labeling.
- •- Any other conditions that do not allow the accomplishment of the clinical trial requisites, such as the abuse of drugs or alcohol.
研究者
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